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Clinical Trials/NCT04374175
NCT04374175
Recruiting
Not Applicable

SERum-bank for PANcreatic Cancer

Centre Hospitalier Universitaire de Saint Etienne2 sites in 1 country400 target enrollmentApril 1, 2020
ConditionsAdenocarcinoma
InterventionsBlood sample

Overview

Phase
Not Applicable
Intervention
Blood sample
Conditions
Adenocarcinoma
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
400
Locations
2
Primary Endpoint
Serum adiponectin concentration
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

This study is about pancreatic cancer. If the diagnostic cancer is done at an early stage (<2cm), the chances of recovery are very good.

But the main problem is there is not any detections means for this cancer. Sadly, when there is a cancer diagnostic , it's already too late in the majority of cases, because the cancer is in an advanced case.

Today, there is no any effective means of detection... Blood markers can be a simple means of early detection

Detailed Description

The purpose of this study is to establish a sero-library in a case-control cohort to assess several potentially useful serum biomarkers, such as adiponectin in the early diagnosis of pancreatic cancer.

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
January 1, 2026
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Documented adenocarcinoma (cytology / anatomopathology), all stages, except if the tumor is immediately resectable and does not require preoperative cytological evidence. In this case, the inclusion and the first collection of the sero bank is done preoperatively. The diagnostic confirmation will therefore be made post-operatively at the risk of being excluded in the event of a different diagnosis.
  • At the start of treatment (before surgery / 1st course of chemotherapy)
  • Age ≥ 18 years
  • Patient affiliated or entitled to a social security system

Exclusion Criteria

  • Patient refusal
  • Acute renal failure
  • Child-Pugh B or C cirrhosis
  • Patient under guardianship or curators
  • Other synchronous cancer or history of cancer \<5 years
  • Language barrier
  • CONTROL GROUP
  • Inclusion Criteria:
  • Age ≥ 40 years
  • Patient affiliated or entitled to a social security system

Arms & Interventions

Adenocarcinoma group

Patients with Adenocarcinoma will be included. They will have blood sample at the inclusion visit and at 3 months, 6 months, 9 months and 12 months after.

Intervention: Blood sample

Control group

Patient with no adenocarcinoma will be included. They will have blood sample at the inclusion visit.

Intervention: Blood sample

Outcomes

Primary Outcomes

Serum adiponectin concentration

Time Frame: Months : 0

Measure by blood sample result Serum adiponectin concentration threshold for which the specificity will be 100% for the diagnosis of pancreatic cancer with a sensitivity of 80%.

Secondary Outcomes

  • Overall survival(Months : 24)
  • Serum CA19.9 concentration(Months : 0, 3, 6, 9, 12)
  • Tumor response and progression rates according to RECIST v1.1(Month 12)
  • Progression-free survival(Months : 24)
  • Serum adiponectin concentration(Months : 3, 6, 9, 12)

Study Sites (2)

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